Applies to the following strength(s): 100 mg ; 200 mg ; 400 mg ; 333 mg
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for HIV Infection
800 mg orally every 8 hours or indinavir 800 mg plus ritonavir 100 to 200 mg orally every 12 hours
Usual Adult Dose for Nonoccupational Exposure
(Not approved by FDA)
Centers for Disease Control and Prevention (CDC) recommendations: 800 mg orally every 8 hours or indinavir 800 mg plus ritonavir 100 to 200 mg orally every 12 hours
Duration: 28 days
Prophylaxis should be initiated as soon as possible, within 72 hours of exposure. Indinavir plus ritonavir plus 2 NRTIs is one of the alternative regimens recommended for nonoccupational postexposure HIV prophylaxis.
Usual Adult Dose for Occupational Exposure
(Not approved by FDA)
Alternate expanded regimen for HIV postexposure prophylaxis:
Preferred dosing: Indinavir 800 mg plus ritonavir 100 mg orally twice a day, in combination with (lamivudine plus zidovudine) or (emtricitabine plus zidovudine) or (lamivudine plus tenofovir) or (emtricitabine plus tenofovir)
Alternative dosing: Indinavir 800 mg orally every 8 hours, on an empty stomach, in combination with (lamivudine plus zidovudine) or (emtricitabine plus zidovudine) or (lamivudine plus tenofovir) or (emtricitabine plus tenofovir)
Duration: Generally 28 days; however, the exact duration of therapy may differ based on the institution's protocol.
Prophylaxis should be initiated immediately, preferably within hours after exposure.
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Mild to moderate hepatic insufficiency due to cirrhosis: 600 mg orally every 8 hours
Concomitant delavirdine (400 mg 3 times a day): Consider reducing the dose to 600 mg orally every 8 hours; indinavir and delavirdine should be administered at least 1 hour apart on an empty stomach
Concomitant itraconazole (200 mg twice a day): Dose reduction of indinavir to 600 mg orally every 8 hours is recommended.
Concomitant ketoconazole: Dose reduction of indinavir to 600 mg orally every 8 hours is recommended.
Concomitant rifabutin: Dose increase of indinavir to 1000 mg orally every 8 hours is recommended; the standard rifabutin dose should be decreased by half.
Strict adherence to the prescribed dose is essential. Patients should not alter the dose or discontinue therapy without consulting their physician.
Indinavir is metabolized by and inhibits CYP450 3A4 isoenzymes and may potentially interact with many drugs. These interactions may be serious and/or life threatening. Drugs contraindicated for coadministration with indinavir include alfuzosin, amiodarone, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, lovastatin, simvastatin, pimozide, oral midazolam, triazolam, alprazolam, and sildenafil for treatment of pulmonary arterial hypertension. Indinavir interacts with several antiretroviral agents and appropriate dosage adjustments should be made when these drugs are used together. Patients should be advised to report all concurrent medications they are taking.
Nephrolithiasis/urolithiasis may occur during indinavir therapy. In some cases, renal insufficiency or acute renal failure has occurred. Patients should keep adequately hydrated by consuming at least 1.5 liters (approximately 48 ounces) of noncaffeinated liquids during the course of 24 hours. Patients should also promptly report any signs and symptoms of nephrolithiasis/urolithiasis such as flank pain and/or hematuria. Therapy should be interrupted briefly (1 to 3 days) or discontinued if necessary.
Acute hemolytic anemia, including cases resulting in death, has been reported in patients treated with indinavir. Once a diagnosis is apparent, appropriate measure for the treatment of hemolytic anemia should be instituted, including discontinuation of indinavir.
Spontaneous bleeding episodes have been reported in hemophiliac patients while receiving protease inhibitors. No causal relationship has been established, however, hemophiliacs should be monitored closely for bleeding during protease inhibitor therapy.
New onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, hyperglycemia, and in some cases, diabetic ketoacidosis have been reported in HIV-infected patients receiving protease inhibitors. However, no causal relationship has been established. Patients may require initiation or dose adjustments of insulin or oral hypoglycemic agents for treatment of these events. Hyperglycemia persisted in some cases after discontinuation of protease inhibitor therapy.
Tubulointerstitial nephritis with medullary calcification and cortical atrophy have been reported in patients with severe leukocyturia (greater than 100 cells/high power field). Close monitoring and frequent urinalyses are recommended for patients with asymptomatic severe leukocyturia. Further diagnostic evaluation may be warranted, and discontinuation of indinavir should be considered in all patients with severe leukocyturia.
Immune reconstitution syndrome has occurred during combination antiretroviral therapy. Patients responding to therapy may develop an inflammatory response to indolent or residual opportunistic infections and require evaluation and treatment.
Indinavir should always be used in combination with other antiretroviral agents. Indinavir should generally not be added as a single agent when antiretroviral regimens are changed due to the development of drug resistance and loss of virological response.
The optimal dosing regimen for use of indinavir in pediatric patients has not been established. A dose of 500 mg/m2 every 8 hours has been administered in uncontrolled studies (n=70); however, pharmacokinetic profiles were not comparable to adults and the risk of nephrolithiasis was increased.
Data not available
Indinavir is best taken with water on an empty stomach 1 hour before or 2 hours after a meal. Alternatively, it may be taken with other liquids or a light meal (dry toast with jelly, juice, coffee with skim milk and sugar, or corn flakes with skim milk and sugar). It should not be taken with a high calorie, fat, or protein meal because absorption is reduced. Indinavir/ritonavir may be taken without regard to meals.
The DHHS Panel on Clinical Practices for Treatment of HIV Infection does not recommend unboosted indinavir as initial therapy due to the frequency of administration and need to take on an empty stomach or with light meals.
If possible, protease inhibitors should be used in combination with 2 nucleoside analogs since triple therapy appears to be the most potent antiretroviral combination available. However, one nucleoside plus a protease inhibitor may be effective if drug intolerance prevents the use of triple therapy.
Indinavir capsules are sensitive to moisture. Patients should be instructed to store and use the drug from the original container and keep the desiccant in the bottle.
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